Clinical Software
489 vendors serving US medical buyers
Browse vendors of clinical software (Medical IT & Digital Health) serving hospitals, clinics, laboratories, and other medical buyers across the United States. MedIndexer connects procurement and clinical-engineering teams with verified vendors supplying clinical software. Browse detailed profiles, compare service areas, and contact vendors directly — free for buyers.
Featured clinical software
CBE Pure Solutions Pty Ltd
Accelagen is a Melbourne-based Contract Research Organisation (CRO) specializing in biopharmaceutical and medical device development. Founded in 2010, the company provides comprehensive clinical research, regulatory affairs, and biometrics services supporting clients from preclinical stages through commercialization. With 51-200 employees, Accelagen offers clinical trial management, strategic regulatory consulting, biostatistics, data management, medical writing, pharmacokinetics, site identification, and product lifecycle management. The company employs a proprietary 'reverse journey mapping' approach to streamline regulatory pathways and market approval across Australia, North America, Asia-Pacific, and Europe. Accelagen has delivered 100+ clinical trials, 339 device approvals, and 57 IND/IDE submissions, maintaining expertise across multiple therapeutic areas including cell and gene therapy, ophthalmology, and other specialties.
ADM TRONICS UNLIMITED, INC.
ADM Tronics Unlimited, Inc. is a full-service electronic medical device innovation firm specializing in design, engineering, development, and manufacturing of diagnostic and therapeutic medical technologies. The company operates an FDA-regulated facility with robust quality control and manufacturing capabilities, bringing medical devices from concept through production. ADMT maintains extensive regulatory expertise across FDA, GMP, CE, ISO 13485, CMDCAS, ETL, and UL standards. The company has developed proprietary non-invasive electrotherapy medical devices spanning multiple therapeutic areas including audiology, physical medicine, wound therapy, neurology, and urology. Key proprietary products include Aurex (tinnitus treatment), Sonotron (non-invasive RF electrotherapy for pain management), and Vet-Sonotron (veterinary non-invasive therapy). ADMT also manufactures specialty water-based formulations and products through subsidiaries including Aqua Based Technologies (primers, adhesives, coatings), Antistatic Industries (static-safe materials and StaticPaint®), and Pros-Aide® (medical prosthetic and special effects adhesive). The company is publicly traded on the OTCQB marketplace under symbol ADMT and has a multi-generational heritage of innovation in electronics and electromechanical design.
Park Dental Research Corporation
Park Dental Research Corporation is a manufacturer and distributor of advanced dental solutions serving dental professionals globally for over 40 years. The company operates four primary product lines: IMTEC® Dental Implants (including mini implants for minimally invasive procedures), Park Dental Aligners™ (custom clear aligner systems with proprietary in-house fabrication), Orchestrate 3D™ (digital treatment planning software for in-office aligner production), and JUELL™ 3D (high-performance dental 3D printers and resins with vapor polishing systems). Park Dental Aligners are manufactured in-house using FDA-cleared proprietary dental resin and FDA-cleared aligner material, enabling rapid turnaround and cost efficiency. The company manufactures and controls every component of aligner production, from software through laboratory processing. JUELL 3D printers support dental manufacturing workflows with vapor polishing capabilities to achieve production-ready surface finishes. All product lines emphasize precision, durability, and ease of clinical use. The company holds FDA clearances for aligner materials and resins and demonstrates commitment to digital dentistry infrastructure. Manufacturing capabilities include scalable 3D printing production, aligner fabrication, and treatment planning software delivery. Park Dental Research attends major industry events including RAPID + TCT and maintains active customer training and education programs.
GenDx LLC
GenDx is a science-based molecular diagnostics company specializing in HLA typing and transplantation diagnostics. The company develops and markets pre- and post-transplant reagent kits, NGS-based HLA typing solutions, and proprietary laboratory software for clinical diagnostics. Product lines include NGSgo-AmpX (next-generation sequencing HLA typing kits for various gene targets including HLA-DRB1, DQB1, and DPB1) and complementary software platforms known for reliability, intuitive navigation, and rapid analysis. GenDx serves transplant laboratories, biobanks, and research institutions globally, with particular emphasis on user-friendly workflows and technical support. The company offers world-class customer support, educational events, and training programs for end users at all proficiency levels. GenDx appears to operate as part of a larger acquisition ecosystem, as evidenced by recent press releases regarding CareDx's transplant lab product division. The company maintains a strong focus on molecular diagnostics quality, laboratory efficiency, and continuous innovation in companion diagnostics and precision medicine applications.
Radialogica LLC
Radialogica is a healthtech company specializing in radiation oncology quality management software and services. The company provides tools and services to evaluate, manage, and enhance the quality and safety of radiotherapy treatment planning and delivery for cancer patients. Radialogica operates in two primary business segments: Clinical Trials Services and Clinical Software Tools. In clinical trials, Radialogica partners with pharmaceutical sponsors, biotechnology companies, CROs, and medical device manufacturers to design and implement comprehensive radiotherapy quality assurance programs. Services include development of RT treatment guidelines, collection and aggregation of DICOM-RT treatment plan data, extraction and evaluation of dosimetric parameters, and prospective or retrospective case reviews. The company has processed over 10,000 radiotherapy case submissions across clinical and research projects, operating across 6 continents, 50+ countries, and 600+ clinical sites. Clinical software offerings include SciMoCa™, a Monte Carlo dose calculation and beam model verification platform for dose verification and plan quality evaluation, and fullAccess™, an integrated radiotherapy data display, communication, and analysis platform enabling multi-disciplinary access and sharing of RT data across the continuum of care. These tools have been deployed at over 225 clinical sites worldwide and have impacted quality of care for over 1.5 million patient treatments. Radialogica addresses the significant variability in treatment planning and delivery inherent in radiation oncology through software-enabled prospective quality review and data analytics. The company serves pharma trials, medical registries, payer benefits management, and provider quality benchmarking programs. All services leverage proprietary software tools and technology infrastructure purpose-built for RT data acquisition, processing, and analysis.
AB Sciex LLC
AB Sciex LLC is a global leader in mass spectrometry and capillary electrophoresis solutions for research, clinical diagnostics, and life sciences applications. The company manufactures a comprehensive portfolio of analytical instruments including triple-quadrupole and QTOF mass spectrometers, HPLC-MS systems, and capillary electrophoresis (CE) instruments. SCIEX serves clinical diagnostic laboratories with FDA-cleared in vitro diagnostic (IVD) medical devices for routine testing; pharmaceutical and biopharmaceutical companies for drug development and biologics characterization; contract research organizations for bioanalysis; environmental and food safety testing facilities; and life science research institutions. Core product lines include the Triple Quad 7500 Plus system, ZenoTOF 7600 QTOF system, Citrine clinical IVD mass spectrometers, ExionLC front-end HPLC systems, and Intabio ZT for charge variant analysis. SCIEX OS is the company's proprietary software platform supporting Windows 11 for data acquisition, processing, and instrument control. The company emphasizes speed, sensitivity, resolution, and ease of adoption across routine and complex analytical workflows. Manufacturing and support operations span multiple global regions, with primary headquarters in Marlborough, MA, and sales/service in Redwood City, CA (Americas) and multiple EMEA locations.
CD Acquisitions, LLC
Certa Dose (operated by CD Acquisitions, LLC) is a medical safety company focused on eliminating dosing errors, particularly in emergency and pediatric settings. The company develops innovative dosing solutions centered on visual verification and cognitive offloading to prevent medication administration errors. Their core mission addresses a critical patient safety gap: studies indicate that 70% of dosing errors occur during drug administration and are missed by electronic ordering systems, with pediatric patients facing 3x higher error risk than adults. The company's primary product offering is the Certa Dose app—a digital solution that enables healthcare providers to visualize the correct medication volume, select appropriate syringes, and document dosing procedures. The app supports weight-based dosing calculations for patients of varying ages and sizes, allowing clinicians to enter actual patient weight or estimate it using length or age parameters when exact measurements are unavailable. The platform employs color-coded confirmation systems and visual verification protocols to enhance accuracy and communication clarity among care teams. Physical product offerings include the PALS (Pediatric Advanced Life Support) Syringe Holder Kit, designed specifically for pediatric emergency codes, and an Epinephrine Convenience Kit for anaphylaxis management across the neonatal-to-adult dosing spectrum. The company also manufactures a pediatric measuring tape for weight estimation during emergencies. These products are positioned as essential tools for emergency departments, pediatric units, and critical care environments where dosing accuracy directly impacts patient survival.
AirStrip Technologies, Inc.
AirStrip Technologies develops clinical surveillance and alarm management software that consolidates siloed clinical data from EMRs, bedside monitors, and medical devices into vendor-agnostic mobile and web applications. The platform provides real-time patient monitoring with embedded waveforms, automated protocol management, and visual decision support across ICU, Emergency, Obstetrics, Cardiology, and Rapid Response units. Core capabilities include multi-patient monitoring (up to 40 patients per screen), diagnostic-quality 12-lead ECG capture with STEMI notifications, maternal and fetal waveform monitoring with real-time visualization, and comprehensive alarm triage and analytics. The software features digitized peer-reviewed clinical protocols, alarm trend analysis and responsiveness metrics, and context-aware clinical linking. AirStrip integrates with diverse hospital infrastructure systems while maintaining HIPAA compliance and meeting ISO 27001 security standards. The platform supports telemetry optimization workflows, door-to-balloon time reduction for acute coronary syndromes, and multi-unit alarm management at scale. Named one of TIME's World's Top HealthTech Companies in 2025 with an "outstanding" rating.
Visibly
Visibly is a digital health platform that enables optical retailers, contact lens distributors, and e-commerce vision care companies to deliver comprehensive vision care services remotely and in-store. The company operates an anywhere-care platform providing vision prescription renewals, visual acuity testing, prescription verification, and automated contact lens and eyewear fulfillment. Visibly's VDAP (Vision Digital Assessment Platform) product received FDA clearance in 2022, positioning the company as a clinically validated solution for vision screening and prescription management. The platform leverages a nationwide network of licensed eye care providers to review and renew customer prescriptions within 24 hours. Core offerings include at-home vision screening, in-store vision testing for brick-and-mortar locations, video consultations with licensed eye care providers for non-emergency conditions (dry eyes, pink eye, allergies), and automated prescription verification to ensure Contact Lens Rule compliance. Visibly also provides fulfillment automation through pre-built integrations with leading contact lens distributors, labs, and eyewear manufacturers. The technology is delivered via a modern GraphQL API supporting single integration across all products. Visibly serves major e-commerce and retail vision care customers including Next Day Contacts, EZContacts, LensDirect, and ROKA. The platform is HIPAA-compliant and designed for seamless white-label deployment with branded test experiences and customizable workflows.
TMRW Life Sciences, Inc.
TMRW Life Sciences manufactures and operates the world's first FDA-cleared automated platform for specimen management and cryogenic storage of frozen eggs and embryos. The company serves fertility clinics with an integrated digital ecosystem comprising RFID-tracked inventory management, ivfOS software database, 24/7 monitoring via Overwatch®, and flexible storage configurations (onsite/offsite, liquid/vapor phase nitrogen). TMRW's core offering includes automated storage systems (robots and vault solutions), specimen transport with GPS tracking, digital chain-of-custody documentation, and a biorepository service for patients. The platform is designed by embryologists and addresses legacy dewar-based specimen management by consolidating inventory control, reducing operational footprint, and minimizing points of failure by up to 94%. Regulatory credentials include FDA clearance, CE marking, and HIPAA-compliant data security. Target market is fertility clinics ranging from single-site practices to multi-clinic networks. The company emphasizes reduced cryoroom footprint, digitized legacy inventory systems, and real-time specimen visibility. Services include clinic support, patient biorepository options, and ongoing platform monitoring.
Zimmer Biomet Holdings, Inc.
Zimmer Biomet is a leading global medical technology company specializing in orthopedic implants, surgical robotics, and digital health solutions. The company manufactures and distributes a comprehensive portfolio of joint replacement systems, trauma devices, spine products, and minimally invasive surgical instruments. Core product lines include the Persona knee system, Z1 hip system, ROSA robotic surgery platform, and specialized solutions for foot & ankle, shoulder, elbow, and sports medicine applications. The company also offers digital care management platforms (mymobility) and AI-enabled surgical navigation systems. Zimmer Biomet serves orthopedic surgeons, hospitals, and surgical centers globally with FDA-cleared and CE-marked devices. Manufacturing capabilities span multiple facilities in North America and internationally, with regulatory compliance including FDA 510(k) clearances and ISO certifications. The company provides comprehensive support including surgical education, training, reimbursement assistance, and equipment servicing. Additionally, Zimmer Biomet distributes specialty products in CMF (craniomaxillofacial), thoracic, trauma, and other surgical specialties through strategic business units.
Tristel Solutions Limited
Tristel Solutions Limited is a global healthcare infection control company specializing in high-level disinfection solutions for medical devices and healthcare surfaces. With over 30 years of industry experience, the company manufactures chlorine dioxide-based disinfectants and digital compliance platforms serving hospitals, clinics, and medical facilities worldwide. The company operates three primary business lines: (1) Tristel brand—high-level disinfectant solutions for medical device decontamination using chlorine dioxide technology; (2) Cache—surface disinfection systems leveraging sporicidal chlorine dioxide formulations; and (3) 3T—a digital traceability and compliance platform integrating with Tristel's disinfection products to provide audit trail documentation and training management. Tristel's products address infection prevention and healthcare-associated infection (HAI) reduction, with demonstrated efficacy against biofilms, spore-forming bacteria (Clostridioides difficile), and emerging pathogens. The company emphasizes sporicidal claims validated against European Norms (EN standards), including EN 17846 certification for sporicidal disinfectant evaluation. Products include the Tristel Trio Wipes System (point-of-care medical device decontamination), Tristel DUO ULT and DUO OPT formulations, Fuse for Medical Surfaces, and JET LUXE and JET PRO delivery systems. Tristel provides comprehensive support services including technical training, product validation, research and development expertise, and after-sales customer support. The company serves diverse healthcare departments including endoscopy, central sterile supply (CSSD), surgery, cardiology, and infection control. Manufacturing and operations are based in the United Kingdom with global distribution capabilities.
MEDHAB LLC
MedHab is a digital health and remote monitoring company that develops wearable devices and software platforms for remote patient monitoring (RPM), chronic care management (CCM), principal care management (PCM), and remote therapeutic monitoring (RTM). The company serves primary care practices, specialty practices (orthopedic, endocrinology, cardiology), long-term care facilities, assisted living communities, federally qualified health centers, and sports performance organizations. MedHab's flagship products include MyHeart+® (Bluetooth and cellular-connected RPM devices with new touchless heart monitor option), MyNotifi Rx® (wrist-worn fall detection device with guided remote rehabilitation exercises), Steprite® (foot sensor for gait, pressure, and range-of-motion monitoring in orthopedic and PT settings), and RPM²® (proprietary footbed power meter for athletic performance analysis). The company also offers integrated care coordination software for pre- and post-operative physical therapy, musculoskeletal recovery, and respiratory monitoring. All products are designed for third-party payer reimbursement under established RPM and remote therapeutic monitoring billing codes. MedHab positions itself as enabling providers to improve patient outcomes, increase engagement, reduce unnecessary in-person visits, and unlock new revenue streams through reimbursable remote care services.
VivoSense Inc.
VivoSense Inc. is a wearable sensor Contract Research Organization (CRO) specializing in digital health technology (DHT) for clinical trials. Founded 14+ years ago, the company provides end-to-end wearable sensor services across 20+ therapeutic areas, serving pharmaceutical sponsors, contract research organizations, and digital health innovators in 30+ countries. The company's core offering includes DHT strategy consultation, wearable device selection and vendor management, protocol development, data collection operationalization, data cleaning and analysis, and clinical validation. VivoSense operates a proprietary DHT platform designed for compliance and auditability in clinical trial environments. The platform enables collection and processing of high-volume, complex sensor data into structured, actionable insights. The company has deployed 70+ wearable sensors to date across diverse disease areas. Clinical operations and data science teams leverage decades of combined experience in digital health technology implementation and sensor data analytics. Recent regulatory engagement includes qualification discussions with the European Medicines Agency (EMA) regarding MEADOW-RETT-BR, a DHT-based measure of apnea events in Rett syndrome patients. Notable partnerships include Biogen, Roche, argenx, Mayo Clinic, and GSK. Services span three phases: study startup (DHT strategy and measure selection), study conduct (operationalization and data collection), and study closeout (data investigation and statistical validation).
CareDx AB
CareDx is a transplant-focused diagnostic and digital health company providing comprehensive solutions across the entire transplant journey. The company delivers advanced diagnostics including rejection monitoring tests and HLA typing kits, digital health platforms, and transplant pharmacy services. CareDx reports performing over 1 million rejection monitoring tests annually, selling approximately 200,000 HLA typing kits per year, and filling 150,000 prescriptions through its transplant pharmacy division. The platform serves approximately 70% of transplant centers with one or more software products. Products and solutions span diagnostic testing, digital workflow platforms, lab innovations, and clinical decision support tools. The company combines laboratory testing capabilities with software platforms designed to simplify clinical workflows and personalize patient care throughout transplant management. CareDx operates as an integrated provider offering both diagnostic services and digital health infrastructure for transplant programs, including pre-transplant evaluation, post-transplant monitoring, and rejection surveillance.
ESAOTE S.P.A.
Esaote S.p.A. is a global medical imaging manufacturer founded in the early 1980s, headquartered in Italy with significant operations in the United States (Fishers, IN). The company specializes in ultrasound systems, magnetic resonance imaging (MRI), and healthcare IT solutions. Their product portfolio includes advanced ultrasound platforms such as the MyLab series (MyLab E85 GTS, MyLab C30 GTS) featuring proprietary technologies like PAM (Photoacoustic Microscopy) for precision imaging across multiple clinical applications including cardiology, urology, and interventional radiology. Esaote also develops intraoperative MRI systems, exemplified by the I-Genius platform for neurosurgery. The company offers comprehensive healthcare IT and enterprise imaging solutions integrated with clinical workflows for prevention, diagnosis, therapy, and follow-up. Esaote serves hospitals, diagnostic imaging centers, and specialty practices globally. The company holds relevant regulatory certifications and maintains robust R&D capabilities focused on clinical needs and market trends. Esaote emphasizes customer care, technical support, and equipment performance optimization. The organization has achieved UNI/PdR 125:2022 gender equality certification and maintains commitment to sustainability and ESG principles. Recent strategic partnerships, such as with Schiller Americas for cardiology imaging expansion, reflect the company's growth trajectory in the North American market.
Imagine Milling Technologies, LLC
Imagine Milling Technologies is a leading North American supplier of digital dentistry equipment, software, and prosthetic solutions. The company manufactures and resells a comprehensive line of CAD/CAM milling systems (imill product line), 3D printers, intraoral and laboratory scanners, and furnaces designed for dental laboratories and practices. Their flagship imill series includes models for zirconia (imill Zr), titanium (imill Ti), chromium cobalt (imill CrCo), wax (imill Wax), and multilayer PMMA, enabling machining of virtually any dental restorative material with spruless abutment capabilities. Imagine USA is the leading North American reseller of exocad CAD software, providing both software and comprehensive training through Imagine Academy. The company offers mist™ implant prosthetics engineered for precision fit with multiple implant system compatibility and includes proprietary components (scan bodies, abutments, prosthetic solutions) with internal hex and conical connection interfaces. Additional offerings include MillBox milling control software, hyperDENT design software, milling materials, milling tools, and 3D print materials. The company operates Imagine Connect™, an outsourcing portal providing CAD design, CAM nesting, and prosthetics production services. Imagine maintains an active educational program through Imagine Academy with video tutorials and training resources, and participates in major dental industry trade shows and digital dental events across North America.
Kemtai
Kemtai is a FDA-listed, CE-marked, HIPAA- and GDPR-compliant digital physical therapy platform that delivers AI-guided exercise and assessment software for rehabilitation, physical therapy, and wellness programs. The company develops computer vision technology that analyzes 111 body data points to provide real-time corrective feedback during exercises without requiring sensors or wearables. Kemtai serves health systems, hospitals, rehabilitation centers, payers (insurers, HMOs, value-based care organizations), digital health platforms, and medical device manufacturers. The platform includes Kemtai CARE, a standalone clinician app for managing patients, assigning exercise protocols, ROM assessments, and tracking adherence and performance metrics. Core capabilities include a library of 2,000+ exercises and movement variations, automated patient notifications, in-app messaging, and white-label customization. Integration is available via robust API framework for embedding into third-party platforms. Clinical validation demonstrates 72% average patient adherence, 33% reduction in in-person appointments, and 95% patient satisfaction. The technology is designed for at-home guided rehab, pre-operative therapy, post-operative recovery tracking, and chronic condition management across MSK, cardiac, neurological, and obesity care. Processing occurs on-device with no video recording, ensuring maximum privacy compliance.
Amphenol DC Electronics
Amphenol DC Electronics (ADCE) is a custom cable assembly and wire harness manufacturing company established in 1979 and acquired by Amphenol in 2013. Headquartered in San Jose, CA with facilities in Nogales Mexico, Penang Malaysia, and additional Mexican operations, ADCE manufactures custom wire harnesses, cable assemblies, integrated electrical-mechanical devices (box builds), overmolded cable assemblies, and discrete assemblies. The company serves aerospace/defense, medical equipment, industrial, and agricultural sectors. For medical applications, ADCE produces cable assemblies and interconnect systems for MRI and CT imaging equipment, patient monitoring devices, surgical robotics, life support systems, and laboratory equipment. Manufacturing capabilities include in-house CNC tooling and molding (30, 55, 85-ton presses), custom overmolding with specialized materials, smart cable design, RF coaxial and semi-rigid coax assemblies, fiber optic cables, and prototype-to-production services. The company holds ISO 13485:2016 certification for medical device manufacturing, IPC-620 Class III certification, UL508 and UL764 certifications, FDA registration, and maintains ITAR, SAM, GDEP, and C-TPAT compliance for defense work. ADCE employs 300+ personnel across its Silicon Valley headquarters (70,000 sq ft) and operates a mature global supply chain with MRP processing, supplier contract pricing, and kanban inventory management.
TICKERWORKS, INC.
TICKERWORKS, INC. manufactures precision pharmaceutical compounding and unit-dose drug packaging solutions for human and veterinary pharmacy applications. The company specializes in innovative applicators, dispensers, and molds designed to improve accuracy, reduce waste, and enhance medication delivery. Core product lines include TICKER® click dispensers for transdermal and topical applications, TROCHE POPS® unit-dose pods for sublingual troches, Pebble Beach and RDT molds for rapid-dissolving tablets and troches, suppository molds in various formulations, and compounding kits. The company also offers lab equipment including centrifuges. TICKERWORKS serves compounding pharmacies, veterinary clinics, and compounding professionals, with particular focus on hormone specialists and animal health practitioners. The organization is ISO 9001 certified and FDA registered, indicating compliance with quality management and regulatory standards for pharmaceutical manufacturing. Products emphasize accuracy, eco-friendly design (30% less plastic than comparable dispensers), and ease of use for pharmacy professionals. The company participates actively in professional conferences including ACVP, WVC, and industry owner summits, indicating strong market positioning within pharmacy and veterinary communities.
DTPM INC.
DTPM INC. is a laboratory solutions distributor and service provider serving physician offices, reference labs, recovery courts, and treatment centers across 47 US states since 1993. The company provides turnkey laboratory solutions including testing equipment, consumables, reagents, and comprehensive lab management services. DTPM offers an FDA EUA-authorized COVID-19 RT-PCR assay validated for detection of multiple SARS-CoV-2 variants including delta and omicron strains. The company distributes Solstice Advanced Materials (formerly Honeywell Research Chemicals) products including DNA/RNA purification kits applicable to bacterial, viral, and fungal samples, as well as complex matrices such as buccal swabs, saliva, respiratory samples, and blood. DTPM FreeWipes are single-ply, lint-free laboratory wipes available in bulk quantities. The company operates an online store offering analyzer consumables, collection supplies, laboratory chemicals, equipment, and general supplies from multiple manufacturers. DTPM has developed over 150 molecular assays and employs staff with 26+ years of laboratory setup experience and 30+ years of research expertise. Services include total program management for labs, dedicated technical support, point-of-care training and certification, and laboratory information systems (LIS) with online data and results management capabilities. The company focuses on high-volume routine and specialty testing, drug testing coordination with recovery and treatment programs, and customized solutions for various laboratory settings.
Associates of Cape Cod, Inc.
Associates of Cape Cod, Inc. (ACC) is a specialist manufacturer of endotoxin and glucan testing reagents, instrumentation, and software for pharmaceutical, biological product, and medical device manufacturers. The company's primary product portfolio centers on Limulus Amebocyte Lysate (LAL) reagents—derived from horseshoe crab blood—used to detect bacterial endotoxins in injectable pharmaceuticals, biologics, and medical devices. ACC also manufactures recombinant endotoxin testing (rBET) alternatives, including recombinant cascade reagents, positioning itself as a supplier of both traditional and next-generation pyrogen detection solutions. The Pyros® eXpress software platform provides integrated quantitative analysis and data management for endotoxin and glucan detection testing across glass tube and plate reader formats, with documented compatibility with Agilent BioTek Epoch 2 microplate readers. ACC operates a Contract Test Services (CTS) laboratory offering third-party endotoxin and glucan contamination testing. The company supports customers through free consultation, methodology guidance, and technical training. ACC maintains a demonstrated commitment to sustainability, including the Horseshoe Crab Sustainability Project (having reared and released over 1 million juvenile horseshoe crabs) and environmental responsibility in manufacturing. The company supplies the regulated biomedical testing market, serving manufacturers of injectable drugs, biologics, and medical devices requiring endotoxin testing for regulatory compliance (FDA, pharmacopeial).
advanced fiber tools GmbH
Advanced fiber tools GmbH is a manufacturer of high-quality fiber optic products for medical, industrial, and scientific applications. The company specializes in developing custom fiber optic solutions tailored to individual customer requirements, with core competencies in medical laser probes for minimally invasive surgery, therapy, and diagnosis. The company serves the medical sector with fiber optic delivery systems and components for laser-based therapeutic and diagnostic procedures. They also manufacture industrial fiber optic cables and fiber bundles across wavelength ranges from 180 nm to 2100 nm, and offer contract manufacturing services. Advanced fiber tools GmbH additionally provides RFID technology solutions for identification of medical instruments, medical laser probes, and consumables to enhance product safety and traceability. The company maintains ISO 13485 certification for medical device quality management systems and employs highly qualified staff with extensive experience in the fiber optics sector. The organization is committed to process-oriented quality management and customized product development.
ARC-One Solutions, LLC
ARC-One Solutions, LLC is a medical device software company founded in April 2020 through a partnership between the American Red Cross and OneBlood, two of the largest blood centers in the United States. The company develops next-generation Blood Establishment Computer Software (BECS) platforms designed to manage safe, efficient, and compliant blood supply chain operations. ARC-One manufactures the Regulated Software Application (RSA), a series of web-based applications that encapsulate data access and business rules for blood collection, manufacturing, labeling, distribution management, and administrative functions. RSA was originally created over 15 years ago by Community Blood Centers of Florida and obtained FDA 510(k) clearance in 2012. The software is currently deployed at OneBlood across Florida, Georgia, Alabama, and the Carolinas, supporting delivery of safe blood products to hospitals and patients. Once fully implemented, ARC-One's redesigned software suite will process approximately 10 million blood products across 56 states and territories, supporting over 50% of the nation's blood supply. The company operates under a strict FDA-regulated quality system and was developed by experienced blood banking professionals. ARC-One serves hospital blood banks, community blood centers, and blood collection facilities requiring comprehensive regulatory compliance and operational efficiency in blood supply chain management.
MonitAir, LLC
MonitAir is a cloud-based FDA-registered Medical Device Data System (MDDS) and HIPAA-compliant digital health platform purpose-built for sleep medicine practices. The platform delivers integrated remote patient monitoring (RPM), remote therapeutic monitoring (RTM), chronic care management (CCM), and telemedicine capabilities in a single dashboard. MonitAir automates workflows for sleep clinics by connecting seamlessly to major PAP devices (ResMed, Philips), pulse oximeters, wearables (Apple Watch, Garmin, Fitbit, Oura), and EHR systems to enable real-time patient data synchronization without manual entry. Core functionality includes CPAP adherence tracking, at-risk patient identification, AI-powered non-adherence prediction (achieving 93% accuracy by day 30), automated patient outreach, compliance reporting, and RPM billing support with CPT code documentation. The platform surfaces actionable clinical insights including compliance metrics, AHI tracking, mask leak monitoring, and wearable-derived sleep patterns, heart rate, SpO₂, and activity data. Flexible tiered pricing supports practices at all stages—from basic adherence monitoring to full RPM/RTM/CCM programs. MonitAir serves 20+ sleep clinics monitoring 6,000+ patients nationwide and is backed by Harvard Innovation Lab. The company emphasizes rapid deployment (5-minute setup), dedicated onboarding support, and clinical validation through a 196-patient randomized controlled trial demonstrating improved CPAP adherence outcomes. Regulatory status: FDA registered; HIPAA compliant with end-to-end encryption.
VasoMedical, Inc.
VasoMedical, Inc. is a cardiovascular technology company with nearly 40 years of experience in cardiac diagnostics and therapy. The company specializes in two primary product areas: Enhanced External Counterpulsation (EECP®) therapy systems and next-generation cardiac monitoring platforms. Their Lumenair™ EECP® system is deployed in over 600 clinics across 40+ countries and is used for non-invasive therapy to improve coronary circulation, helping patients with angina and heart failure improve exercise tolerance and quality of life. In cardiac monitoring, VasoMedical offers the ARCS cloud-native platform, an FDA-cleared system for Holter, Extended Holter, Event, and Multi-Channel Telemetry (MCT) monitoring. ARCS features artifact-reduction algorithms, unified workflow management, and high-volume scanning capabilities designed to reduce manual rework and accelerate turnaround times. The company has analyzed over 1 billion heartbeats and delivered 12+ million hours of cardiac monitoring data. VasoMedical also provides the Advanced Cardiac Therapy (ACT) Program, a comprehensive utilization and operations model to help health systems optimize EECP program performance across cardiology, rehabilitation, and administrative workflows. The company serves hospitals, cardiology practices, rehabilitation clinics, and health systems ranging from private practices to major healthcare networks. Products are supported by FDA clearance for monitoring algorithms and established reimbursement pathways. VasoMedical combines hardware, software, and operational consulting to address both clinical and workflow challenges in cardiac care.
Randox Laboratories Ltd.
Randox Laboratories is a global leader in diagnostic solutions with over 40 years of expertise in clinical laboratory, molecular, and point-of-care diagnostics. The company manufactures a comprehensive portfolio including the RX Series clinical chemistry analyzers, Vivalytic molecular point-of-care systems, and Evidence Series immunoassay analyzers. Randox provides open-channel reagents covering more than 100 disease areas including autoimmune disorders, cancers, and emergency/critical care diagnostics. The company operates as the world's largest external quality assessment (EQA) provider through RIQAS and QCMD platforms, serving over 100,000 users across 145 countries. Core offerings include quality control solutions (Acusera brand), third-party diagnostic assays, molecular infectious disease controls, and QC data management software. Beyond laboratory equipment, Randox operates multiple specialized service divisions: Contract Manufacturing (OEM partnerships), CDx and Biopharma services (biomarker development), Genomics (end-to-end sequencing with in-house bioinformatics), Pathology Services (sample collection and advanced testing), Toxicology (forensic drug detection for 600+ substances), Workplace Drug and Alcohol Testing, Food Diagnostics (antimicrobial and toxin screening), and Randox Health (preventative healthcare and home testing kits). The company serves clinical laboratories, reference labs, pharmaceutical companies, food/beverage industry, workplace testing, and forensic applications globally.
3D Systems, Inc.
3D Systems is a leading provider of additive manufacturing (3D printing) solutions for industrial and healthcare applications. The company manufactures a comprehensive portfolio of commercial 3D printers capable of producing plastic, metal, elastomer, composite, wax, and biocompatible parts at point-of-need, significantly reducing production timelines compared to traditional subtractive manufacturing. Core product lines include direct metal printing systems, plastic-based printing platforms, and specialized materials for aerospace, automotive, dental, medical device, and semiconductor industries. 3D Systems also develops AI-powered software for design-to-production workflows and provides application innovation consulting services. In healthcare, the company serves dental labs, orthopedic manufacturers, and biomedical researchers; notable medical applications include custom dental solutions (NextDent jetted denture systems with EU MDR certification), patient-specific surgical guides, and bioprinted tissue scaffolds. The company maintains certifications for medical device manufacturing and serves enterprises including Airbus, Lucid, Jabil, and academic institutions (MIT, Imperial College, ETH Zurich). Manufacturing capabilities span both hardware production and materials development, with a global service and support network.
Right Way Medical LLC
Right Way Medical is a US-based medical device distributor specializing in infusion pumps, disposables, biomedical services, and asset-tracking software for post-acute healthcare providers. The company distributes volumetric and enteral feeding pumps from manufacturers including Fresenius Kabi (Agilia Connect), Amsino (Puggle), Smith Medical (CADD SOLIS VIP), and Eitan (Sapphire Multi-Therapy System). Beyond product distribution, Right Way Medical offers comprehensive biomedical repair and maintenance services for medical equipment. The company developed Right Track, a proprietary asset-tracking software platform designed to minimize human error and streamline inventory management and equipment compliance for healthcare facilities. Right Way Medical operates multiple regional offices across the United States (Arizona, Texas, Illinois, Georgia, Pennsylvania) and serves post-acute care settings, pharmacies, and specialty medical product companies. The company maintains partnerships with numerous leading medical device manufacturers and has built relationships with major healthcare organizations since at least 2014. Services are characterized by direct account management, responsive support, and customized solutions tailored to provider needs.
Data Innovations LLC
Data Innovations LLC is a software solutions provider specializing in laboratory enterprise management and middleware platforms. The company develops vendor-neutral connectivity and workflow optimization software for clinical laboratories, serving 6,000+ hospitals and labs across 80+ countries. Their primary product line includes Instrument Manager (middleware platform for lab instrument connectivity and autoverification workflows), EP Evaluator (instrument performance validation and regulatory compliance reporting), and Lab GPS (real-time connectivity monitoring and downtime troubleshooting). Data Innovations enables labs to streamline operations, improve productivity, reduce manual tasks, accelerate test turnaround times, and ensure compliance through customizable automation and centralized workflow management. The company positions itself as supporting all laboratory disciplines with unlimited scalability and flexible, vendor-agnostic architecture. Their client base includes major health systems (Sanford, UNC Rex, Valley Children's Hospital, University of Iowa, VA Medical Centers) and laboratory networks. Data Innovations operates globally with headquarters in Colchester, Vermont and regional offices in São Paulo, Hong Kong, and Brussels, employing 1,200+ drivers/support staff worldwide.
Miridia Technology Inc.
Miridia Technology Inc. is a 20-year-old B2B supplier of professional acupuncture, auriculotherapy, and complementary wellness devices for licensed practitioners and clinics. The company manufactures and distributes FDA-registered electroacupuncture systems (Pointoselect Digital), digital meridian imaging technology (AcuGraph), auriculotherapy software (Auriculo 360), cranial electrotherapy stimulation devices (CES Ultra), photobiomodulation therapy systems (Photizo, Gunalight), and jade/tourmaline heating pads (Jade Vitality). Products span diagnostic tools (point detection and treatment), therapeutic delivery platforms, and consumer wellness applications, including veterinary photobiomodulation (Photizo VetCare). Miridia also provides acupuncture software (Points), reference charts, and professional training through webinars and continuing education units (CEUs). The company serves acupuncturists, chiropractors, naturopaths, veterinarians, and wellness practitioners globally, with strong emphasis on integrating traditional Eastern medicine with modern clinical instrumentation. Known for responsive customer service, technical support, equipment servicing, and a 4.8-star rating (1,051 verified reviews). No explicit regulatory certifications (510(k), ISO 13485) mentioned on homepage, though Pointoselect is referenced as FDA-registered.
Mahe Medical USA
Mahe Medical USA operates a proprietary healthcare AI platform that integrates fragmented hospital systems to deliver real-time, actionable intelligence for cost reduction, revenue optimization, and clinical decision-making. The platform combines internal hospital data (EHR, billing, imaging, inventory, clinical notes, physician behavior) with external intelligence (FDA data, HHS compliance, supply chain, manufacturing costs, outcomes trials, vendor data) to generate predictive insights and executable recommendations. The company maintains access to 135,000+ FDA-registered, medically equivalent devices, enabling hospitals to identify cost-effective alternatives, capture missed reimbursement, optimize coding, and enable new procedural care. The platform is fully HIPAA-compliant and trained on real manufacturing cost data, FDA registration data, and clinical/operational datasets. Mahe Medical operates its own LLM rather than relying on commercial AI models, continuously learning from industry datasets. The company demonstrates measurable impact: case studies show recovery of missed reimbursement (up to $53M+ in net revenue increase), infection risk reduction through device transition recommendations, and systematic cost optimization. The partnership model aligns incentives with hospital success—clients pay a nominal setup fee plus a percentage of verified savings and revenue increases, ensuring Mahe Medical is compensated only on measurable outcomes. The platform addresses a critical healthcare gap: most systems provide static data or historical reporting; Mahe Medical transforms that data into real-time situational awareness and context-driven recommendations that drive clinical and financial outcomes.
TRUE-See Systems, Inc
TRUE-See Systems, Inc develops medical photography color calibration and verification software designed to standardize clinical imaging across dermatology, wound care, and other visual documentation workflows. The company's core offering is a patented calibration slate featuring clinically relevant colors, including the Monk Scale, which corrects for lighting, distance, and device variability to ensure consistent, clinically reliable images regardless of capture device or operator. Each calibrated photograph is assigned a unique QR-certified reference number, creating a tamper-resistant audit trail that supports clinical documentation integrity, regulatory compliance, and legal defense. The platform utilizes advanced AI and information security technologies to correct for smartphone camera enhancement artifacts and standardize photos across inpatient, outpatient, and home care settings. TRUE-See has validated its approach across 2+ million calibrated photos from 700+ clinicians serving 800,000+ patients. The system is HIPAA-compliant, SOC 2 Type II audited, and aligned with CIA Triad information security principles. The solution addresses a documented clinical problem: over half of medical photographs contain color errors that can lead to diagnostic confusion, misinterpretation of wound healing status, infection indicators, and vascular conditions. TRUE-See's technology is particularly applicable to dermatology, wound management, surgical documentation, and any clinical specialty requiring objective photographic evidence.
NOVEL GMBH
NOVEL GmbH is a global leader in force and pressure measurement systems, specializing in capacitive sensor technology since 1979. Headquartered in Munich, Germany, the company designs and manufactures high-precision load distribution measurement systems used in research, development, medicine, and industrial applications. Their portfolio includes innovative wireless in-shoe pressure distribution systems (pedar®), plantar force measurement devices (loadsol®), floor-based pressure mapping (emed®), and versatile pressure sensors for diverse surfaces (pliance®). These systems employ calibrated capacitive transducers in matrix configurations, enabling reproducible measurements in medical applications such as diabetic foot syndrome monitoring, sports rehabilitation, gait analysis, and prosthetics optimization. NOVEL's customers span space agencies, automotive manufacturers, medical device companies, major universities, and leading research institutions worldwide. The company is recognized for precision, accuracy, and commitment to quality in enabling world-class clinical research and development.
uLab Systems, Inc.
uLab Systems, Inc. is a Memphis-based dental technology company specializing in digital orthodontic treatment planning, clear aligner manufacturing, and ancillary orthodontic products. The company operates a vertically integrated platform combining proprietary cloud-based design software, in-office and outsourced manufacturing capabilities, and concierge treatment planning services. Core offerings include: uDesign® AI-Assisted Treatment Planning software (available on cloud platform uDesign® Cloud 2.0) for comprehensive case design and indirect bonding (IDB) tray setup; uAssist® Concierge Treatment Planning for delegated case setup; and uSmile® Clear Aligners and Retainers manufactured from proprietary Reva™ thermoforming material, claimed to be 17% thinner than competing products. The platform supports comprehensive, hybrid (fixed appliance + aligner), and limited/à la carte treatment workflows, with options for in-office manufacturing and practice-branded packaging. uLab Systems targets independent and group orthodontic practices with tools designed to increase case complexity capability (hybrid/combo cases), reduce chairtime through IDB efficiency, and provide workflow flexibility. The company reports 94% customer recommendation rate and 98% product satisfaction for uSmile aligners and retainers. Manufacturing, software hosting, and treatment planning services are centralized or delegated based on practice preference. No publicly disclosed FDA 510(k) clearance, ISO certification, or regulatory credentials are mentioned on the site.
Advanced LifeSciences Pvt. Ltd.
Cosmereg is a regulatory compliance consultancy specializing in assisting cosmetics, dietary supplements, food, and medical device manufacturers in achieving market authorization across North America, Europe, and the Middle East. The firm provides end-to-end regulatory guidance including FDA Agent services for US market entry, Responsible Person designation for EU/UK/Canada cosmetics compliance, product classification, labeling review, facility registration, and submissions (510(k) for medical devices, CPNP for EU cosmetics, CNF for Canada cosmetics). The company serves multinational clients across 50+ countries with expertise in FDA regulations, Health Canada requirements, and European regulatory frameworks, helping manufacturers navigate complex compliance pathways and avoid delays, penalties, or product recalls.
BioIntelliSense Inc.
BioIntelliSense develops continuous patient monitoring systems for in-facility and home care settings. The company's flagship product, the BioButton wearable device, captures multiparameter vital signs and biometric data in real time, enabling proactive detection of patient deterioration. The system integrates flexible connectivity options (BioMobile app, BioHub Cellular gateway, BioHub Wi-Fi gateway) with BioDashboard clinical intelligence software for exception-based monitoring and analysis. Clinical studies demonstrate that continuous monitoring reduces unplanned ICU admissions, rapid response team activations, and average length of hospital stay. The platform supports operational efficiency initiatives including length-of-stay reduction, virtual rounding optimization, and telemetry overuse reduction. BioIntelliSense targets hospitals, health systems, skilled nursing facilities, assisted living, home health agencies, and remote patient monitoring providers. The company emphasizes evidence-based outcomes from peer-reviewed publications, including research in the Journal of Clinical Medicine and British Journal of Anaesthesia. Products are designed for both acute care floor monitoring and post-acute care transitions, with reimbursement support for remote patient monitoring (RPM) programs. The system is described as medical-grade and designed for healthcare provider organizations only, not direct consumer purchase.
Neelyx Labs, Inc
Neelyx Labs is a CLIA-certified clinical laboratory providing end-to-end testing infrastructure and services for population health programs. The company specializes in custom-branded at-home test kit development, laboratory analysis, and digital health integration serving public health agencies, health plans, digital health companies, employers, and research organizations. Capabilities include kit design and fulfillment with prepaid return logistics, multilingual support (12+ languages), high-complexity laboratory testing with rapid turnaround (24-hour average result delivery), electronic result reporting, and chain-of-custody management. Neelyx operates a white-label laboratory model, enabling digital health companies and health plans to offer branded testing experiences while outsourcing testing operations. The company provides program design consultation, workflow optimization, regulatory navigation support, and proprietary software platforms for ordering, tracking, results delivery, and population health dashboards. Neelyx has shipped 500,000+ kits and can launch new programs in under six weeks. Service markets include community screening, disease surveillance, workplace wellness, return-to-work protocols, and clinical research. The company positions itself as mission-driven toward community health and public health priorities, with dedicated account management and full-stack operational responsibility rather than transactional mega-lab services.
YPSOMED AG
Ypsomed AG is a Swiss-based leading developer and manufacturer of self-injection systems for liquid medications, with over 40 years of innovation in drug delivery technology. The company specializes in customized injection platforms for pharmaceutical and biotech partners, including disposable pens, autoinjectors (such as YpsoMate), and wearable on-body devices. Ypsomed operates a global manufacturing network with facilities in Burgdorf, Schwerin, Changzhou, and Solothurn, employing over 2,000 people. The company provides comprehensive services spanning device development, clinical trial support (Clear-to-Clinic program), human factors engineering, and digital health integration. Products are designed for subcutaneous self-administration of therapeutics across chronic disease categories including diabetes, autoimmune conditions, and specialty biologics. Ypsomed emphasizes sustainable manufacturing practices, having achieved LEED Platinum certification at its Changzhou facility, and maintains 100% renewable energy sourcing for operations.
JAM-Labs Corp
JAM-Labs Corp is a medical technology company specializing in AI-powered surgical environment solutions and operating room integration systems. The company designs and manufactures hardware, software, FPGA, embedded systems, and mechanical solutions for perioperative environments. Their product portfolio includes advanced OR recording and visualization devices, integration systems, and intelligent digital platforms that enhance surgical workflows, patient safety, and OR efficiency. JAM-Labs serves hospitals and surgical centers with solutions designed for surgeons, nursing staff, trainees, and healthcare administrators. The company emphasizes real-time data insights, automation through AI algorithms, error prevention systems, and seamless integration with existing perioperative workflows. Their offerings address OR performance optimization, staff collaboration, surgical documentation, and procedure recording with high-resolution 4K visualization. JAM-Labs targets institutional healthcare markets and has demonstrated presence in catheterization labs and surgical suite environments, with customer testimonials from hospital networks and specialized surgical centers.
NeckCare Holding
NeckCare develops objective assessment and rehabilitation systems for cervical spine dysfunction. The company manufactures the NeckCare System™, a wearable sensor device with Bluetooth connectivity paired with a web-based clinical platform, used by over 250 providers across North America to evaluate and treat patients with neck pain, headaches, concussion, whiplash-associated disorders, and dizziness. The system measures cervical range of motion, proprioception (joint position sense), and sensorimotor control through the proprietary Butterfly Test®. The NeckCare Platform automates assessment protocols, generates normative data comparisons, and enables real-time progress tracking. NeckCare Home™ is a camera-powered remote rehabilitation extension requiring no additional hardware beyond a standard personal device camera. The system is FDA-listed and incorporates decades of clinical research. Primary markets include physical therapy clinics, chiropractic practices, sports medicine facilities, and academic medical centers. The system generates objective documentation supporting clinical decision-making and insurance claim substantiation. Customers include University of Miami, Johns Hopkins Medicine, and UFC Performance Institute.
RaySearch Laboratories AB (publ)
RaySearch Laboratories is a Swedish medical software company specializing in oncology treatment planning and management solutions. The company develops advanced software platforms that enable cancer treatment centers to optimize radiation therapy, chemotherapy, and adaptive care workflows. RaySearch's primary offering is RayCare, an integrated oncology information system designed to support thousands of clinics worldwide. The company collaborates with leading cancer centers to translate scientific advancements into clinical solutions. RaySearch operates in the radiation oncology and comprehensive cancer care software space, serving hospitals and specialized cancer treatment facilities globally. The company is publicly traded (AB publ) and maintains active participation in major oncology conferences including ECIO and IBA's International Symposium on Proton Therapy. Recent expansion includes market entry in China with initial RayCare orders.
Jazz Imaging
Jazz Imaging manufactures intraoral dental X-ray sensors and dental imaging software. The company produces two primary sensor product lines: SOLO (Size 2 imaging with Size 1 comfort) and MINOR (Size 1 imaging with Size 0 comfort), both utilizing premium CMOS technology to deliver high-quality radiographs with superior resolution and low-dose imaging optimization. Jazz sensors feature a high active area ratio, slim and comfortable patient-facing design, and are designed for seamless integration with major dental imaging software platforms without TWAIN protocol limitations. The company also offers Classic, a proprietary dental imaging software suite built in-house, available free to Jazz sensor users, providing intuitive exam templates, full-mouth X-ray (FMX) functionality, and straightforward EHR/practice management software integration. Jazz Imaging emphasizes direct-from-manufacturer sales with transparent pricing, offering both subscription (Jazz Club membership starting at $119/month with $498 activation) and traditional purchase options ($5,299 standalone sensor purchase). All sensors include lifetime warranty support, fast sensor replacement, and 30-day money-back guarantee. Products are manufactured in the USA with no import tariffs. The company serves dental practices ranging from solo practitioners to multi-office organizations and positions itself as a cost-effective alternative to incumbent dental sensor brands while maintaining diagnostic image quality and patient comfort standards.
A-dec, Inc.
A-dec Inc. is a family-owned global leader in dental equipment manufacturing, established in 1964 and headquartered in Newberg, Oregon. The company designs and manufactures ergonomic dental operatory systems distributed through authorized dealers in over 100 countries. A-dec's comprehensive product portfolio includes dental chairs (A-dec 500, 400, 300, and specialty models), delivery systems with advanced touchscreen controls, surgical and LED lighting, dental stools, and modular cabinet systems (Inspire 500 and 300 lines). The company also provides mechanical room solutions including QuietCore+ air compressors and dry vacuums, infection control systems (vacuum line cleaning, waterline maintenance), handpiece integrations, sterilization centers, and digital connectivity through the A-dec+ platform with AI-powered features. Known for innovations such as advanced evacuation systems and Clean Water Systems, A-dec emphasizes quality, ergonomics, and customer service with Certified Ergonomics Assessment Specialists supporting dental practices globally.
MONOBIND, INC.
Monobind Inc. is a leading independent in vitro diagnostics (IVD) manufacturer founded in 1978 and headquartered in Lake Forest, California. The company develops and manufactures over 160 immunoassay products across its AccuBind® ELISA and AccuLite® CLIA platforms, serving clinical laboratories, point-of-care facilities, and direct-to-patient applications globally. Monobind's portfolio spans multiple assay formats—microplate, monotest, magnetic-bead, lateral flow assays (LFA), and microarray technologies—enabling testing of serum, plasma, and whole blood samples. The company supports scalable workflows from manual reader-based systems to fully automated random-access analyzers. Beyond finished assays, Monobind supplies high-quality biomaterials and specialty reagents including buffers and stabilizers for the global diagnostics industry. Operating under FDA registration and ISO 13485 certification, the company distributes CE-marked products to laboratories and partners in over 100 countries worldwide.
Laboratorio Pablo Cassara
Biotech Research Group (BRG) is a full-service regulatory and product development consulting firm headquartered in Tampa, Florida. BRG specializes in expedited commercialization pathways for pharmaceutical, biologic, and medical device companies navigating FDA and global regulatory requirements. The firm maintains a global network of expert consultants across 60+ countries with specialized expertise in toxicology, pharmacokinetics, statistics, epidemiology, and pharmacovigilance. BRG's core services span biologics (BLA, tissue registrations, vaccines, gene therapy), medical devices (510(k), PMA, PMN applications, implants, surgical devices), pharmaceutical drugs (NDA, ANDA, IND, OTC), quality assurance (ISO clean room operations, audits, SOP implementation, FDA adverse event reporting), and specialty services including emergency use authorizations, expert witness testimony, and literature reviews. The firm emphasizes FDA compliance leadership, clinical research design, and quality management as keys to regulatory success, offering cost- and time-effective tailored product development plans.
Spok, Inc.
Spok, Inc. is a healthcare communications software company serving 2,200+ hospitals globally. The company delivers clinical information to care teams through secure, HIPAA- and HITECH-compliant platforms designed to improve patient outcomes and care delivery workflows. Spok's unified platform, Spok Care Connect, integrates multiple communication channels including secure messaging, on-call scheduling, contact center solutions, facility alerting, clinical care notifications, paging services, and clinical test result management. The platform automates critical clinical workflows such as patient alerts, clinician consults, code calls, and test result notifications. Core modules include enterprise directory management with role-based access, EHR-driven clinical alerting, rapid code and response activation, acuity-based routing and escalation, and IVR automation for routine requests. The solution is device-agnostic, enabling communication across smartphones, tablets, and traditional devices. Spok also serves government and emergency services with enhanced E9-1-1 accuracy and integrated PSAP tools. Customers report 70+ million messages sent monthly through Spok solutions. The company has 30+ years of experience in healthcare communications and maintains partnerships with leading healthcare systems including VCU Health and Mercy Iowa City.
Overjet
Overjet is a dental AI software company providing an integrated platform for clinical decision support and administrative automation. The company develops FDA-cleared vision AI for x-ray analysis that detects disease and anatomical structures to improve diagnosis and case acceptance. Core products include Vision AI (x-ray analysis software), IRIS (AI-native dental imaging software with auto-populated templates and image enhancement), Dental Insurance Verification (automated coverage verification across 300+ payers with code-level breakdowns), and Voice AI Suite (unified clinical intelligence combining imaging insights with voice-to-text documentation and automated charting). The platform serves dentists, dental service organizations (DSOs), educators, and dental insurers. Overjet's technology streamlines clinical workflows, reduces administrative burden through automated insurance verification and charting, and improves patient understanding through AI visualizations. The company is trusted by major dental organizations including Dental Care Alliance, CoreDental, Jefferson Dental, Aligned Dental Partners, and others. Products integrate with existing dental practice management systems and consolidate imaging and AI capabilities without separate cloud storage fees. Regulatory clearance includes FDA approval for vision AI diagnostic capabilities.
Shenzhen Ruiyi Business Technology Co., Ltd.
RENPHO is a global consumer wellness technology brand founded in 2016, headquartered in California with international offices. The company specializes in connected smart health devices and wearables that enable individuals to track and optimize personal health metrics through advanced body composition analysis, vital sign monitoring, and recovery/wellness solutions. Core product categories include smart body composition scales (MorphoScan series using DF-BIA technology), wearable health tracking devices (LYNX smart ring, smart tape measures), eye and foot massage systems, therapeutic massage guns with temperature control, air compression recovery boots, and beauty/aesthetic devices (LED light therapy masks). All devices integrate with RENPHO's free Health App ecosystem, which serves 20M+ users globally with data analytics, goal tracking, and community features. Products are FSA/HSA eligible and clinically validated, with distribution across 100+ countries. The brand targets health-conscious consumers, fitness enthusiasts, and individuals managing chronic health conditions through accessible, app-connected health monitoring technology.
Sonio
Sonio is a cloud-based AI-powered ultrasound reporting software platform specializing in OB-GYN and prenatal care. The platform integrates with ultrasound machines from all manufacturers to deliver FDA-cleared and CE-marked AI diagnostics, quality control, and automated reporting workflows. Key capabilities include Sonio Detect (AI-assisted anomaly detection), automated image management with intelligent view sorting, real-time quality control verification, visual checklists for exam completeness, integrated practice analytics, and seamless connectivity to EHRs, PACS, billing systems, and external providers via HL7/FHIR/eFAX. The platform enables sonographers and OB-GYNs to standardize reporting, improve diagnostic accuracy, reduce manual data entry, and enhance prenatal care access globally. Sonio operates on secure cloud or on-premise infrastructure with SOC2 Type II, HIPAA, ISO 13485, and GDPR compliance.
SUN NUCLEAR CORPORATION
Sun Nuclear Corporation is a global leader in radiation oncology quality assurance (QA) solutions, serving over 6,000 healthcare facilities in more than 130 countries. Founded in 1984 and headquartered in Melbourne, Florida, the company specializes in comprehensive QA platforms for radiation therapy and diagnostic imaging, with solutions deployed in over 90% of U.S. cancer treatment centers and 60% of global facilities. Sun Nuclear provides advanced dosimetry verification, machine QA, patient-specific plan verification, and AI-powered treatment planning tools. The portfolio includes proprietary detector technologies, phantom systems, and integrated software solutions designed to enhance patient safety and streamline clinical workflows. In 2021, Sun Nuclear was acquired by Mirion Technologies, strengthening its position in radiation safety innovation. The company offers extensive clinical support, training, and service backed by over 300 years of combined team expertise and 34 patents in radiation oncology and diagnostic imaging QA.
KMC Systems
HiArc is a medical device engineering and manufacturing company specializing in design, engineering, and manufacturing services for diagnostics and life sciences companies. Founded in 1980 and based in Merrimack, New Hampshire, the company employs 200–500 people and operates as a strategic partner across the full product lifecycle—from concept development and engineering design through manufacturing and ongoing support. HiArc brings deep expertise in laboratory automation, robotics, precision engineering, microfluidics, thermal control, optics, and motion control. The company serves startups and global original equipment manufacturers in the diagnostics, biotech, and medtech sectors, with over 40 years of partnership experience. HiArc emphasizes collaborative, quality-driven processes that align with client goals and deliver regulatory-compliant, real-world-ready solutions.
GastroKlenz Inc. dba CloudCath
CloudCath is a digital health medical device company that develops remote monitoring solutions for peritoneal dialysis (PD) patients. The company's flagship product, CloudCath Connect™ PD, is an add-on device for PD cyclers that utilizes optical analysis, IoT sensors, machine learning, and cloud computing to measure turbidity in dialysate effluent. By quantifying fluid analysis rather than relying on subjective visual assessment, CloudCath enables early detection of peritonitis and other complications—on average 3.1 days before patient-reported symptoms. Clinical evidence demonstrates a 45% reduction in peritonitis-related hospitalization and 56% reduction in catheter loss. The system seamlessly integrates with major PD cyclers (Baxter and Fresenius), provides real-time notifications to patients and clinicians, and supports continuous home-based monitoring to shift care from in-center facilities. This innovative approach enhances patient outcomes, improves therapy adherence, and reduces the need for emergency interventions in end-stage renal disease management.
NATIONAL DISTRIBUTION & CONTRACTING, INC.
National Distribution & Contracting, Inc. (NDC) is a healthcare supply chain solutions provider headquartered in Nashville, Tennessee. The company operates through multiple business segments: a B2B distributor and manufacturer solutions division offering market intelligence platforms, supply chain optimization, 3PL services, master distribution, and business management solutions including contract and rebate processing; and Preferred Medical, a national wholesale distributor of medical supplies and equipment for infusion therapy and post-acute care markets. NDC serves over 450 manufacturer partners, 1,500 distributor and integrated delivery network (IDN) partners, and provides access to products for 6,800+ healthcare providers. Core capabilities include proprietary data analytics for competitive intelligence, group purchasing organization (GPO) services, vaccine buying groups, pharmaceutical sourcing for generic injectables, talent development programs, and marketing solutions. Preferred Medical specializes in distribution of IV therapy products, infusion pump services including repair, maintenance and rental, Wolf-Pak® brand consumables, and post-acute care supplies to home infusion pharmacies, infusion centers, ambulatory clinics, and long-term care facilities. The company provides scalable warehousing, fulfillment, and regulatory support infrastructure. NDC operates as a master distributor enabling manufacturers to access wide provider networks and independent distributors to leverage shared scale and national brand access.
SamanTree Medical SA
SamanTree Medical SA is a Swiss medtech company specializing in intraoperative digital pathology solutions. The Histolog® Scanner is a real-time tissue imaging system based on massively parallel confocal microscopy technology, enabling surgeons to visualize fresh tissue microstructures without specimen damage. The system provides rapid specimen preparation (15 seconds) and scanning (~1 minute per surface) with 2 µm per-pixel resolution, delivering high-resolution imaging of tissue surfaces for tumor margin assessment during cancer surgery. The scanner maintains specimen integrity while providing microstructural information to support surgical decision-making across breast, prostate, lung, and brain cancer procedures. Complementary consumables include the patented Histolog Dip (fluorescent stain) and single-use Histolog Dish. Digital collaboration tools enable remote physician consultation and annotation. FDA-cleared and CE-marked globally.
ZOLL Medical Corporation
ZOLL Medical Corporation manufactures an integrated portfolio of medical devices, software, and services focused on emergency care, cardiac resuscitation, and patient monitoring. The company serves EMS and fire departments, hospitals, military organizations, public safety agencies, and non-acute care settings including dental and physician offices. Core product lines include automated external defibrillators (AEDs), professional monitor/defibrillators (Zenix), wearable defibrillators (LifeVest), ventilators, CPR feedback and automated CPR devices, and implantable cardiac management systems (remedē System for central sleep apnea). ZOLL also offers comprehensive software and data analytics solutions for EMS/fire operations and hospital administration through ZOLL Data Solutions, addressing billing optimization, documentation, and clinical performance management. The company owns or partners with ZOLL Itamar, a leader in sleep apnea diagnosis and management. Products feature Real CPR Help technology, intuitive interfaces, configurable clinical parameters, and integrated data collection for continuous quality improvement. ZOLL emphasizes clinical training, education platforms (E-Learning), and continuous product support. The company is part of Asahi Kasei and maintains FDA clearances, EU MDR approval, and established regulatory standing across markets. Serves diverse customer bases from lay rescuers and community organizations to hospital systems and military medical units.
Tensentric
Tensentric is an ISO 13485:2016 certified engineering and manufacturing firm specializing in design, development, prototyping, and volume production of medical devices, in-vitro diagnostics (IVD), and life sciences systems. Founded in 2009 and headquartered in Boulder, Colorado, the company employs 83–96 engineers and scientists, many with over 20 years of experience across electromechanical systems, microfluidics, bioprocessing, and human factors optimization. With over 300 completed development projects and 75+ patents, Tensentric delivers turn-key system design from concept through volume manufacturing. Core competencies include custom-engineered instruments and consumables, point-of-care diagnostic platforms, cell and gene therapy bioprocessing equipment, and complex integrated systems for sample handling, biochemical analysis, and detection. Services encompass design and development, human factors and use-safety engineering, new product introduction (NPI), and dedicated manufacturing. Clients include Medtronic, BD, Philips, Johnson & Johnson, Stryker, and other major medtech OEMs. In 2022, the firm received strategic investment from GenNx360 Capital Partners to expand manufacturing and business development capabilities.
Radformation, Inc.
Radformation is a healthcare technology company specializing in AI-driven automation software for radiation oncology workflows. Founded in 2016 and based in New York, the company develops intelligent tools that enhance efficiency, reduce errors, and improve cancer treatment planning across oncology clinics. Radformation's integrated platform supports the complete treatment lifecycle—from automated contouring and planning to quality assurance, treatment monitoring, and billing automation. Key offerings include AutoContour (480+ deep-learning anatomical structures), EZFluence (3D automated planning), ClearCheck (plan evaluation), ClearCalc (independent dose calculation), RadMonteCarlo (Monte Carlo calculations), ChartCheck (real-time treatment monitoring), ChartCheck Adaptive (adaptive dose tracking), QuickCode (billing QA), and RadMachine (machine QA). The platform seamlessly integrates with Eclipse™ TPS and supports photon, electron, proton, and brachytherapy modalities. With over 1,400 clinic installations and multiple regulatory clearances, Radformation enables cancer treatment centers to standardize workflows, increase patient throughput, and deliver safer, higher-quality radiation treatments.
Movano Inc. dba Movano Health
Movano Health is a wearable medical device company specializing in personalized health monitoring technology. The company develops smart rings and wearable sensors featuring patented radio frequency (RF) technology for non-invasive, cuffless vital sign monitoring including blood pressure, glucose levels, and pulse oximetry. The Evie Ring is designed for women's health with trend tracking and Apple Health integration, while the EvieMED Ring is FDA 510(k)-cleared for clinical-grade pulse oximetry. Movano's proprietary RF chip enables miniaturized, accurate biometric sensing without traditional cuffs or continuous calibration. The company advances clinical validation through partnerships with health researchers and ongoing FDA-regulated clinical studies to expand approved indications for glucose and blood pressure monitoring.
ATMOS Medizintechnik GmbH & Co. KG
ATMOS Medizintechnik is a German-headquartered medical technology manufacturer with over 130 years of expertise and 300+ employees worldwide. The company develops and supplies medical suction systems, ENT (otolaryngology) workstations and treatment units, gynecology diagnostic and therapeutic equipment, and flexible endoscopy systems for swallowing diagnostics (FEES). ATMOS maintains 15 subsidiaries and approximately 70 national agencies internationally, serving hospitals, clinics, private practices, and homecare providers. Core product lines include electrical and pneumatic suction devices (ATMOS and MEDAP brands), ENT treatment units (C 21/C 31 Economy series, S 61 CORIAN), flexible HD video endoscopes (ATMOS Scope), ENT case management software, and gynecology solutions focused on cervical cancer diagnosis and treatment. The company emphasizes intuitive design, high infection control standards, workflow optimization, and user safety. ATMOS offers comprehensive post-sale services including technical support, repairs, maintenance, spare parts supply, and device modernization. Products are designed for clinical environments with emphasis on ease of use and reliability for end-users. The company maintains ISO and CE certifications typical of European medical device manufacturers and distributes globally through both direct channels and regional representatives.
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